Dezoxide Suppresses Sufentanil-induced Cough

Not Applicable

Not yet recruiting

• Conditions: Sufentanil-induced Cough
• Interventions: Drug: Intravenous dizocine

• Registration Number: NCT05532449
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

Dizocine (0.03 mg/kg) or saline followed by sufentanil 0.4ug/kg was administered, and induction was completed with 3 min of observation. Heart rate and mean arterial pressure (MAP) were recorded before induction of anesthesia, before and 1 min after intubation, and side effects during induction, such as vomiting, hypoxemia (SpO2 \<90%), or other expected effects. The number of coughs was recorded in both groups, and the severity of cough was defined as follows: mild, 1-2 coughs; moderate, 3-4 coughs; severe, 5 or more coughs.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-04
• Last Update Submitted: 2022-09-04
• Study First Posted: 2022-09-08
• Last Update Posted: 2022-09-08
• Study Start: 2022-09-12
• Primary Completion: 2022-09-12
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• Patients admitted for elective valve surgery, artificial vessel replacement or coronary artery bypass graft surgery; Age 18~80 years old; Sex is not limited; ASA class II~III; NYHA Class II-III; Patients or their family members have signed the clinical trial informed consent form

Exclusion Criteria

• Upper respiratory tract infection within the last two weeks; Long history of smoking; chronic obstructive pulmonary disease; Highly reactive airway diseases such as bronchitis and asthma; Presence of high cranial pressure, high eye pressure, pulmonary alveolus; Malignant tumor, hematological disease, severe liver and kidney dysfunction, recent serious infection, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dezocine	Intravenous dizocine	intravenous dezocine (0.03mg/kg diluted to 5 ml)

Primary Outcome Measures

Name	Time	Method
sufentanil-induced cough	2 minutes after intubation	rate and severity of cough after sufentanil injection

Secondary Outcome Measures

Name	Time	Method
SpO2	2 minutes after intubation	SpO2 during induction of general anesthesia
heart rate	2 minutes after intubation	heart rate during induction of general anesthesia
mean arterial pressure	2 minutes after intubation	mean arterial pressure during induction of general anesthesia